Senior Manager in Astellas QA
Astellas Pharma Inc. • markham, Canada
Role Description
Join Astellas as a Senior Manager specializing in Pharmacovigilance QA. Oversee critical audits and ensure regulatory compliance in this impactful role.
As the Senior Manager of Pharmacovigilance Quality Assurance, you will lead quality assurance activities that support the PV system. This role encompasses developing training, ensuring regulatory inspection readiness, and managing quality issues across the organization. You will work closely with cross-functional teams to enhance Astellas’ quality systems and drive continuous improvement initiatives.
Key Responsibilities:
• Execute comprehensive global audit programs and report findings
• Provide expert GPvP advice and coaching within Astellas
• Develop readiness strategies for upcoming regulatory inspections
• Collaborate with service providers for effective QA delivery
• Manage critical non-conformities and implement corrective actions
Requirements:
• Bachelor's degree required
• Seven years in Pharmacov...
As the Senior Manager of Pharmacovigilance Quality Assurance, you will lead quality assurance activities that support the PV system. This role encompasses developing training, ensuring regulatory inspection readiness, and managing quality issues across the organization. You will work closely with cross-functional teams to enhance Astellas’ quality systems and drive continuous improvement initiatives.
Key Responsibilities:
• Execute comprehensive global audit programs and report findings
• Provide expert GPvP advice and coaching within Astellas
• Develop readiness strategies for upcoming regulatory inspections
• Collaborate with service providers for effective QA delivery
• Manage critical non-conformities and implement corrective actions
Requirements:
• Bachelor's degree required
• Seven years in Pharmacov...